Blood collection device

ABSTRACT

A safety needle assembly has a needle hub and a needle cannula projecting from the hub. Wings project transversely from the hub to facilitate manipulation and positioning of the needle assembly. A shield is hingedly attached to the needle hub and can be rotated from a first position where the needle cannula is exposed to a second position where the needle cannula is shielded. At least one latch may be disposed on the shield for secure locked engagement with the hub, the wings and/or the tubing extending from the hub. A spring may also be provided for propelling the shield into the second position.

RELATED APPLICATION

[0001] This application is a non-provisional of U.S. Provisional PatentAppl. No. 60/366,367, filed Mar. 20, 2002.

FIELD OF THE INVENTION

[0002] The invention relates to a medical apparatus with a needle forfluid collection or infusion and with a hinged shield for safelyenclosing the medical apparatus.

BACKGROUND OF THE INVENTION

[0003] Disposable medical devices having piercing elements foradministering a medication or withdrawing a fluid, such as hypodermicneedles, blood collecting needles, fluid handling needles and assembliesthereof, require safe and convenient handling. The piercing elementsinclude, for example, pointed needle cannula or blunt ended cannula.

[0004] The above-described medical devices often include a pair offlexible plastic wings mounted to or near the needle hub. The wings canbe folded into face-to-face engagement with one another, and hencedefine a convenient handle for gripping and manipulating the needlecannula. The wings also can be rotated away from one another and can betaped into face-to-face contact with the skin of the patient.

[0005] Accidental sticks with a needle cannula can be painful and cantransmit disease. As a result, most needle assemblies are employed withrigid means for enclosing the needle cannula both prior to use and afteruse. Protection prior to use typically is achieved by a rigid plastictube that has a proximal end frictionally mounted to the needle hub anda distal end that extends beyond the distal end of the needle cannula.The plastic tube is removed and discarded immediately prior to use ofthe needle cannula. Protection after use of the needle cannula typicallyis achieved by a shield that can be moved relative to the needle cannulafrom a first position where the needle is exposed to a second positionwhere the needle cannula is safely within the shield. Shields of thistype typically include means for releasably holding the shield in itsfirst position and for holding the shield more securely in its secondposition. The retention of the shield in its second position shouldprevent any accidental re-exposure of the used needle cannula andpreferably should prevent or substantially complicate an intentionalattempt to reuse the needle cannula.

[0006] A demand exists for a medical device that provides secureshielding and an easy operation.

SUMMARY OF THE INVENTION

[0007] The invention is directed to a fluid collection or infusion set.The fluid collection or infusion set comprises a length of flexibleplastic tubing with opposite proximal and distal ends and a passageextending between the ends. A fitting is connected securely to theproximal end of the flexible plastic tubing.

[0008] The fluid collection or infusion set further comprises a safetyneedle assembly secured to the distal end of the flexible tubing. Theneedle assembly includes a needle hub with a proximal end, a distal endand a passage extending between the ends. Portions of the passageadjacent the proximal end of the hub are configured for secureengagement with the distal end of the flexible plastic tubing.

[0009] The needle assembly further includes a needle cannula havingopposite proximal and distal ends and a lumen extending between theends. The proximal end of the needle cannula is affixed securely to thedistal end of the needle hub so that the lumen through the needlecannula communicates with the passage through the needle hub and withthe passage through the flexible tubing. The needle assembly may furtherinclude a needle protector removably mounted over the needle cannula andextending sufficiently to cover the distal end of the needle cannula.

[0010] The needle assembly further includes a pair of flexible wingsthat extend transversely from the needle hub. The wings may be formedseparately from the needle hub and may be mounted to a portion of theneedle hub. Thus, the needle hub may be formed from a first plasticmaterial selected for rigidity, while the wings may be formed from asecond plastic or elastomeric material selected for flexibility.Alternatively, the wings may be unitary with the hub, and thinnedportions of the wings adjacent the hub may function as hinges.

[0011] The needle assembly may further comprise a safety shield hingedlyconnected to the needle hub for rotation from a first position where theneedle cannula is exposed for use to a second position where the needlecannula is safely enclosed within the shield. The shield may comprisemeans for permanently locking the shield in the second position. Thelocking means may comprise at least one resiliently deflectable cannulafinger lock that snaps into engagement with the needle cannula when theshield reaches the second position. Alternatively, or additionally, thelocking means may comprise means for lockingly engaging the needle huband/or the plastic tubing.

[0012] The locking means may comprise a first locking means forreleasably holding the shield in the first position and a second lockingmeans for permanently holding the shield in the second position. Thefirst locking means functions to prevent the shield from interferingwith normal usage of the needle assembly. The second locking means,however, permanently shields the needle cannula after use andsubstantially prevents intended or unintended re-exposure of the usedneedle cannula.

[0013] The shield may be hinged to rotate about an axis alignedorthogonal to the needle cannula. The axis of rotation of the shield maybe substantially parallel to the wings when the wings are rotated intotheir substantially coplanar orientation on opposite respective sides ofthe hub. Alternatively, the axis of rotation of the shield may bealigned substantially normal to the wings when the wings are in theircoplanar orientation and projecting from opposite lateral sides of theneedle hub.

[0014] The needle assembly may further include biasing means for urgingthe shield into the second position. The biasing means may be formedunitarily with the hinged connection of the shield to the needleassembly. More particularly, the biasing means may be an over centerhinge that initially biases the shield toward the first position.However, sufficient rotation of the shield will move the over centerhinge into a position where the hinge urges the shield into the secondposition. Alternatively, the biasing means may comprise a separatespring having a first portion secured to the needle hub and a secondportion secured to a location on the shield. The connections of thespring to the shield and the hub are spaced from the hinged connectionbetween the shield to the hub.

[0015] The needle assembly may further include a dorsal fin thatprojects from the needle hub at a location spaced angularly from thewings. The dorsal fin can be used to facilitate digital manipulation ofthe needle assembly during a medical procedure. The dorsal fin mayinclude or be connected to the shield. Thus, forces exerted on thedorsal fin after use can enable the shield to be moved from the firstposition to the second position.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]FIG. 1 is a perspective view of a first embodiment of theinvention with the shield in the open position.

[0017]FIG. 2 is a perspective view similar to FIG. 1, but showing theshield in the closed position.

[0018]FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. 2.

[0019]FIG. 4 is a cross-sectional view similar to FIG. 3, but showing asecond embodiment.

[0020]FIG. 5 is a cross-sectional view similar to FIGS. 3 and 4, butshowing a third embodiment.

[0021]FIG. 6 is a perspective view of a safety needle assembly inaccordance with a fourth embodiment.

[0022]FIG. 7 is a cross-sectional view similar to FIGS. 3-5, but showingthe embodiment of FIG. 6.

[0023]FIG. 8 is a side-elevational view partly in section of a safetyneedle assembly in accordance with a fifth embodiment of the invention.

[0024]FIG. 9 is a view side-elevational of the assembly illustrated inFIG. 8, but showing the shield in the closed position.

[0025]FIG. 10 is a cross-sectional view taken along line 10-10 in FIG.9.

[0026]FIG. 11 is a perspective view of safety needle assembly inaccordance with a sixth embodiment of the invention.

[0027]FIG. 12 is perspective view of the safety needle assembly shown inFIG. 1I, but depicting the shield in the closed position.

[0028]FIG. 13 is a side elevational view of a seventh embodiment of thesafety needle assembly with the shield in an open position.

[0029]FIG. 14 is a side elevational view of the safety needle assemblyshown in FIG. 13, but with the shield in the closed position.

[0030]FIG. 15 is a perspective view of a safety needle assembly inaccordance with an eighth embodiment of the invention with the shield inthe open position.

[0031]FIG. 16 is a perspective view of the safety needle assembly of theeighth embodiment, but showing the shield in the closed position.

[0032]FIG. 17 is a perspective view of a safety needle assembly inaccordance a ninth embodiment, with the shield in an open position.

[0033]FIG. 18 is a perspective view similar to FIG. 17, but showing theshield in the closed position.

[0034]FIG. 19 is a side elevational view of a safety needle assembly inaccordance with a tenth embodiment, with the shield in the openposition.

[0035]FIG. 20 is a side elevational view of the safety needle assemblyshown in FIG. 19, but with the shield in the closed position.

[0036]FIG. 21 is a perspective view of the safety needle assembly inaccordance with an eleventh embodiment, with the shield in the openposition.

[0037]FIG. 22 is a side elevational view, partly in section, of thesafety needle assembly shown in FIG. 21 with the shield in the openposition.

[0038]FIG. 23 is a side elevational view, partly in section, showing thesafety needle assembly of FIGS. 21 and 22, but with the shield in theclosed position.

[0039]FIG. 24 is a perspective view of a safety needle assembly inaccordance with a twelfth embodiment of the invention, and with theshield in the open position.

[0040]FIG. 25 is a perspective view of a safety needle assembly shown inFIG. 24, but with the shield in the closed position.

[0041]FIG. 26 is a perspective view of a safety needle assembly inaccordance with a thirteenth embodiment of the invention with the shieldin the open position.

[0042]FIG. 27 is a side elevational view of the safety needle assemblyshown in FIG. 25 at the start of a shielding operation.

[0043]FIG. 28 is a side elevational view similar to FIG. 26, but showingthe safety needle assembly after completion of shielding.

[0044]FIG. 29 is a perspective of a fourteenth embodiment of theinvention with the shield in the open position.

[0045]FIG. 30 is a perspective view of the safety needle assembly shownin FIG. 29, but with the shield in the close position.

DETAILED DESCRIPTION OF THE INVENTION

[0046] A first embodiment of a fluid collection/infusion set inaccordance with the subject invention is identified generally by thenumeral 10 in FIGS. 1-3. Fluid collection/infusion set 10 includes alength of flexible plastic tubing 12, a proximal fitting 14, a needleassembly 16, a winged grip 18 and a shield 20.

[0047] Tubing 12 includes a proximal end 26, a distal end 28 and apassage extending between the ends. Tubing 12 may be a conventionalintravenous tubing used in conventional blood collection sets orinfusion sets. Proximal connector 14 is molded unitarily from a plasticmaterial and includes a proximal end 30, a distal end 32 and a passageextending between the ends. Portions of the passage adjacent distal end32 are configured to telescope tightly over proximal end 26 of tubing 12so that the passage through tubing 12 communicates with the passagethrough proximal connector 14. Adhesive, welding or the like can beemployed to achieve a permanent connection between tubing 12 andproximal connector 14. Proximal end 30 of connector 14 defines a femaleLuer connector that can be mated with an appropriate male Luerconnector. The male Luer connector may include a proximal needle cannulathat can be placed in communication with an evacuated tube.Alternatively, a male Luer connector at the distal end of a conventionalprior art syringe can be connected directly to proximal connector 14 forinfusing a medication into the patient. In this instance, a separatemale Luer cap can be provided for closing the proximal end of connector14. Other fittings may be engaged threadedly with proximal connector 14to achieve specific intended applications. Additionally, proximalconnectors of other configurations may be employed to achieve aparticular objective.

[0048] Needle assembly 16 includes a needle cannula 34, a needle hub 36and a needle protector 38. Needle cannula 34 has a proximal end 40, adistal end 42 and a lumen 44 extending between the ends. Distal end 42of needle cannula 34 is beveled to a sharp tip.

[0049] Needle hub 36 is molded unitarily from a plastic material such aspolycarbonate, polypropylene, polyethylene, acrylic, polystyrene andABS. Preferably needle hub 36 is molded from a transparent ortranslucent material to enable observation of blood or other fluidflowing through needle hub 36. Needle hub 36 includes a proximal end 46,a distal end 48 and a stepped passage (not shown) extending between theends. Portions of the passage adjacent proximal end 46 are dimensionedto receive distal end 28 of tubing 12. More particularly, distal end 28of tubing 12 is telescoped into the passage of needle hub 36 and isbonded in position adjacent proximal end 46 of needle hub 36. Portionsof the passage adjacent distal end 48 of needle hub 36 are dimensionedfor slidable receipt of proximal end 40 of needle cannula 34. Moreparticularly, proximal end 40 of needle cannula 34 is securedpermanently to needle hub 36 by epoxy and/or a mechanical affixation.

[0050] Needle protector 38 is a rigid cylindrical tube with a lengththat exceeds the projecting length of needle cannula 34 from needle hub36. Needle protector 38 defines an inside diameter approximately equalto the outside diameter of the distal tip of needle hub 36. Thus, needleprotector 38 can be telescoped over needle cannula 34 and frictionallyretained on the distal tip of needle hub 36.

[0051] Winged grip 18 is molded from an elastic material such aspolyolefin, polyvinyl chloride or other such elastomeric polymers.Winged grip 18 includes flexible wings 54 and 55 and a tubular mount.The tubular mount includes an interior passage that is dimensioned forsnug engagement over needle hub 36. Wings 54 and 55 are formedrespectively with locking apertures 57 and 58.

[0052] Safety shield 20 of the first embodiment has a proximal end 60, adistal end 62 and a generally U-shaped channel 63 extending from distalend 62 toward proximal end 60. Proximal end 60 of shield 20 is hinged toneedle hub 36 at a location close to proximal end 46 of needle hub 36.More particularly, shield 20 may be molded unitarily with needle hub 36,and the hinged connection between shield 20 and needle hub 36 may definea living hinge at or near proximal end 60 of shield 20. Alternatively,proximal end 46 of needle hub 36 may define a hinge member that can besnapped into engagement with a mating hinge member at proximal end 60 ofshield 20. Channel 63 of shield 20 is cross-sectionally dimensioned toreceive needle cannula 34 therein. Additionally, distal end 62 of shield20 is spaced from proximal end 60 by a distance that exceeds thedistance between proximal end 46 of needle hub 36 and distal end 42 ofneedle cannula 34. Thus, shield 20 can be rotated from a first position,as shown in FIG. 1, where needle cannula 34 is fully exposed for use toa second position, as shown in FIG. 2 where needle cannula 34 is safelyshielded.

[0053] Shield 20 includes structure for locking shield 20 in the secondposition substantially surrounding needle cannula 34. More particularly,as shown in FIG. 1, shield 20 is formed with tabs 64 and 65 that projecttransversely from proximal portions of shield 20. Tabs 64 and 65 definea large and conveniently located surface for receiving digital pressureto pivot shield 20 from the first position to the second position.Locking fingers 67 and 68 project rigidly from portions of tabs 64 and65 that face wings 54 and 55. Locking finger 67, 68 includes lockingdetents 70, 71 at locations thereon spaced from tabs 64 and 65 by adistance substantially equal to the thickness of wings 54 and 55.Locking fingers 67 and 68 are disposed and dimensioned to pass throughlocking apertures 57 and 58 in wings 54 and 55. Wings 54 and 55 andlocking fingers 67 and 68 will deform slightly in response to forcesthat move shield 20 into the second position around needle cannula 34.After sufficient rotation, locking detents 70 will pass entirely throughlocking apertures 57 and 58 in the respective wings 54 and 55. Wings 54and 55 and locking fingers 67 and 68 then will resiliently return to anundeflected condition for securely locking shield 20 in the secondposition around needle cannula 34 and preventing reuse of needle cannula34. Locking fingers 67 and 68 may be supplemental by cannula fingerlocks formed in channel 63 and configured for engaging cannula 34 whenshield 20 is in the second position.

[0054] The second embodiment of the needle assembly is illustrated inFIG. 4, and is structurally and functionally very similar to the firstembodiment. Hence, comparable parts are provided with identicalreference numerals, and a detailed description of the second embodimentis not provided. The second embodiment differs from the first embodimentin that wings 54 and 55 need not be provided with locking apertures.Additionally, tabs 64 a and 65 a are larger than tabs 64 and 65 in thefirst embodiment and have a proximal-distal dimension that exceeds theproximal-distal dimension of wings 54 and 55. Two locking fingers 72 and74 project from tab 64 a and are dimensioned to engage proximal anddistal edges of wing 54 a. Two identical locking fingers (not shown)project from wing 55. Thus, each wing 54, 55 is engaged at two locationsfor securely holding shield 20 in the second position surrounding needlecannula 34, as shown most clearly in FIG. 4. As in the first embodiment,wing locking fingers 72 and 74 can be supplemented by cannula locks.

[0055] A third embodiment is illustrated in FIG. 5 and includes a needlecannula 34, a needle hub 36 and wings 54 and 55 substantially identicalto the first embodiment. At least wing 54 is formed with lockingaperture 58 as in the first embodiment. A shield 20 is hinged to needlehub 36 as in the first embodiment and can be rotated from a firstposition where needle cannula 34 is exposed to a second position whereneedle cannula 34 is shielded. A locking finger 68 b projects fromshield 20 and is received in locking aperture 56 of wing 54. Lockingfinger 68 b is in the form of a ratchet, and thus differs from thelocking fingers of the first two embodiments. More particularly, ratchetlocking finger 68 b extends rigidly from shield 20 through an arcsubstantially concentric with the axis of rotation of shield 20. Ratchetlocking finger 68 b is formed with a plurality of pawls 82, each ofwhich is configured to slightly resist a forward movement of shield 20and to prevent a return movement of shield 20 back toward the firstposition. Shield 20 will be retained in the second position by lockedengagement of pawl 82 closest to shield 20 and may be retained furtherby a cannula finger lock.

[0056] A fourth embodiment is illustrated in FIGS. 6 and 7, and includesa needle cannula 34, a needle hub 36 and wings 54 and 55, substantiallyas in the second embodiment. A shield 20 is hinged to needle hub 36 forrotation from a first position where needle cannula 34 is exposed to asecond position where needle cannula 34 is shielded. Shield 20 includesa slot 84 that extends distally from the hinged connection to hub 36. Arigid dorsal fin 86 projects from needle hub 36 at a locationequiangularly spaced from wings 54. Dorsal fin 86 is disposed to passthrough slot 84 for all rotational movements of shield 20 from the firstposition to the second position. Dorsal fin 86 is formed with aplurality of detents disposed to engage portions of shield 20 on eachside of slot 84 at each of a plurality of different rotationalorientations of shield 20 relative to needle cannula 34 and needle hub36. In particular, a first detent 88 is dimensioned and disposed to holdshield 20 releasably in the first position where shield 20 isrotationally spaced from needle cannula 34. A final detent 89 isdisposed to permanently lock shield 20 in the second positionsurrounding needle cannula 34. One or more additional detents may bedisposed between first detent 88 and the final detent 89. As in theprevious embodiments, engagement of shield 20 with the detents on dorsalfin 72 can be supplemented by cannula finger locks formed within shield20.

[0057] A fifth embodiment is illustrated in FIGS. 8-10, and includes aneedle cannula 34, a needle hub 36, plastic tubing 12 extending from theproximal end of needle hub 36 and wings 54 and 55 projecting from needlehub 36 substantially as in the second embodiment. The safety needleassembly of FIGS. 8-10 further includes a shield 90 that is functionallysimilar to shield 20 described above and illustrated in FIGS. 1-7. Inparticular, shield 90 is hingedly connected to needle hub 36 and can berotated from a first position where needle cannula 34 is exposed to asecond position where needle cannula 34 is safely shielded. Shield 90,however, is structurally different from the preceding embodiments. Inparticular, shield 90 has a proximal end 92, a distal end 94 and ahinged connection 96 hingedly mounted to needle hub 36. Portions ofshield 90 adjacent hinged connection 96 define a window 98 through whichneedle hub 36 extends. A channel 100 extends between window 96 anddistal end 94 and opens in a direction for receiving needle cannula 34,substantially as in the preceding embodiments. Thus, the distancebetween hinged connection 96 and distal end 94 is sufficiently great toensure complete shielding of needle cannula 34. Portions of shield 90between window 98 and proximal end 92 define a channel 102 that isdimensioned to receive plastic tubing 12. Channel 102 is formed with aplurality of resilient deflectable tubing locks 104. Tubing locks 104are dimensioned and configured to resiliently deflect in response tocontact with flexible tubing 12. However, tubing locks 104 will returnresiliently to an undeflected condition when shield 90 reaches thesecond position for preventing rotation of shield 90 back toward thefirst position. As in the other embodiments, shield 90 also may beprovided with a cannula finger lock in channel 100 for securely andredundantly locking shield 90 in the second position.

[0058] A sixth embodiment is illustrated in FIGS. 11 and 12 and includesa needle cannula 34, a needle hub 36, and wings 54 and 55 projectingfrom needle hub 36, as in the other embodiments. A shield 110 is hingedrelative to needle hub 36 for movement from a first position whereneedle cannula 34 is exposed to a second position where needle cannula34 is shielded. However, shield 110 is not hinged directly to needle hub36. Rather, shield 110 is hinged to a shield base 112 which in turn issecurely mounted to proximal end 40 of needle hub 36. Shield base 112 isformed with a pair of opposed latches 114 disposed to lockingly engageshield 110 when shield 110 is rotated into the second position. Thus,shield 110 is part of a structure formed unitarily with shield base 112and latches 114. Locking can be achieved entirely with structures on theunitarily formed shield 110 and shield base 112. Shield 110 may furtherinclude a cannula finger lock for redundantly locking shield 110 withneedle cannula 34.

[0059] Aspects of the invention described above pertain to the lockingof the shield in the second position so that the needle is safelyshielded. Other aspects of the invention pertain to structure forfacilitating movement of the shield toward the second position. Moreparticularly, a seventh embodiment of the invention is depicted in FIGS.13 and 14, and includes a safety needle assembly having a needle cannula34, a needle hub 36 and wings 54 and 55 substantially as in thepreceding embodiments. A shield 20 is hingedly connected to needle hub36. More particularly, proximal end 60 of shield 20 is connectedunitarily to distal end 48 of needle hub 36 by an over center hingeidentified generally by the numeral 120. Hinge 120 includes a primaryhinge 122 and a plurality of articulated legs 124 connecting locationson hub 36 to locations on shield 20 spaced from primary hinge 122. Legs124 are aligned to one another substantially at a right angle whenshield 20 is in the first position of shield 20. Legs 124 are biasedtoward a straight angle as shield 20 is rotated about hinge 120 from thefirst position toward the second position. As shield 20 approaches thesecond position, legs 124 pass beyond a position of maximum extensionand are biased back toward their original right angle disposition foraccelerating shield 20 into the second position.

[0060] An eighth embodiment is illustrated in FIGS. 15 and 16 andincludes a needle cannula 34, a needle hub 36, and wings 54 and 55substantially as in the preceding embodiments. The safety needleassembly of FIGS. 15 and 16 further includes a shield 20 with opposedproximal and distal ends 60 and 62. Proximal end 60 of shield 20 isjoined unitarily to distal end 48 of hub 36 by a unitary hinge 130.Hinge 130 is biased into an orientation where shield 20 extendssubstantially linearly and distally beyond hub 36. However, hinge 130permits shield 20 to be rotated approximately 180° in a proximaldirection so that shield 20 substantially abuts hub 36 to define thefirst position of shield 20 relative to needle cannula 34 and hub 36.

[0061] Hub 36 further includes a shield latch 132 projecting fromproximal end 46 of hub 36. Latch 132 is configured to engage distal end62 of shield 20 when shield 20 is in the first position. An actuatinglever 134 projects outwardly and proximally from shield latch 132.Actuating lever 134 can be depressed by a thumb or forefinger to deflectlatch 132 sufficiently to disengage from shield 20. As a result, hinge130 resiliently expands to the undeflected condition and propels shield20 to the second position substantially surrounding needle cannula 34.As in the other embodiments, shield 20 is provided with at least onecannula finger latch for trapping cannula 34 and holding shield 20 insurrounding relationship to cannula 34.

[0062] A ninth embodiment of the invention is illustrated in FIGS. 17and 18, and is similar in several functional respects to theabove-described eighth embodiment. More particularly, the ninthembodiment comprises a needle assembly with a needle cannula 34, aneedle hub 36 and wings 54 and 55 as described above. Shield 20 isarticulated to distal end 48 of hub 36 by a unitary hinge 130 that isbiased to urge shield 20 into the second position substantiallysurrounding needle cannula 34. However, hinge 130 permits shield 20 tobe rotated against the biasing forces of hinge 130 and into a firstposition where shield 20 is aligned substantially at a right angle toneedle cannula 34, as shown in FIG. 15.

[0063] Dorsal fins 134 and 135 project up from the respective wings 54and 55. Dorsal fin 134 and 135 have proximal ends 136 and 137,respectively, and distal ends 138 and 139, respectively. Dorsal fin 134is connected to wing 54 at roots 140 disposed intermediate proximal anddistal ends 136 and 138. A similar root (not shown) joins dorsal fin 135to wing 55. Dorsal fins 134 and 135 are substantially parallel to oneanother and are spaced sufficiently for apart to permit shield 20 to bedisposed between dorsal fins 134 and 135 when shield 20 is in the firstposition. Dorsal fins 134 and 135 further are formed with shield locks142 on the opposed facing surfaces of dorsal fins 134 and 135. Locks 142are disposed and configured to lockingly trap shield 20 and retainshield 20 in the first position.

[0064] The needle assembly of FIGS. 17 and 18 can be used by grippingopposed dorsal fins 134 and 135 at locations distal of root 140 forguiding needle cannula 34 into a targeted blood vessel or other sourceof bodily fluid. Needle cannula 34 is withdrawn from the patient aftersufficient fluid has been collected or infused. Portions of dorsal fins134 and 135 adjacent proximal ends 136 and 137 then are squeezed towardone another. This causes a pivoting of dorsal fins 134 and 135 aboutroots 140 so that distal ends 138 and 139 of dorsal fins 134 and 135move further apart. As a result, shield latches 142 are disengaged fromshield 20 and hinge 130 propels shield 20 into the second position. Asin the other embodiments, cannula finger locks on shield 20 engagecannula 34 to lock shield 20 in the second position. Thus, shielding canbe effected merely by shifting the location of gripping forces from amore distal position on dorsal fins 134, 135 to a more proximalposition.

[0065] The seventh through ninth embodiments achieved shieldingassistance by the inherent biasing forces of a unitarily formed hinge.The tenth embodiment, however, employs a separate spring to facilitateshielding. More particularly, the tenth embodiment of the subjectinvention, as shown in FIGS. 19 and 20, relates to an assembly withneedle cannula 34 and a needle hub 36. Needle hub 36 includes a distalend 48 from which needle cannula 34 extends. A shield 20 is hinged toneedle hub 36 at a location near distal end 48 of shield 36. Shield 20can be rotated from a first position where shield 20 is spaced fromneedle cannula 34 to a second position where shield 20 protectivelysurrounds needle cannula 34. The assembly further includes a spring 150that functions much like over center legs 124 of the sixth embodimentand biased hinges 130 of the seventh and eighth embodiments. Moreparticularly, spring 150 extends from hub 36 to shield 20. Spring 150has a proximal end 152 connected to hub 36 and a distal end 154connected to shield 20. Spring 150 is disposed to one side of the hingedconnection between shield 20 and hub 36 when shield 20 is in the firstposition. Thus, spring 150 helps to hold shield 20 in the firstposition. Shield 20 can be moved manually from the first position towardthe second position. This movement requires the user to overcome theforces exerted by spring 150. This movement also causes distal end 152of spring 150 to move through an arc about the hinged connection betweenshield 20 and hub 36. After sufficient movement, spring 150 will moveacross the hinged connection between shield 70 and hub 36. At thatpoint, spring 150 will begin assisting the movement of shield 20 towardthe second position. Shield 20 is provided with cannula finger locks forlocked engagement with needle cannula 34 when shield 20 reaches thesecond position.

[0066] The eleventh embodiment of the subject invention is illustratedin FIGS. 21-23 and employs a spring in a manner different from the tenthembodiment. More particularly, the eleventh embodiment includes needle34, a needle hub 36 and wings 54 and 55. Needle hub 36 includes a distalend 48 and needle cannula 34 extends therefrom. A needle shield 20 isconnected hingedly to distal end 48 of needle hub 36 and can move from afirst position where needle cannula 34 is exposed to a second positionwhere needle cannula 34 is shielded. A dorsal fin 160 projectssubstantially rigidly upwardly from hub 36 at a location equiangularlyspaced between wings 54 and 55. Dorsal fin 160 includes a distal face162 with a locking detent 164 projecting distally therefrom. Lockingdetent 164 is configured to lockingly engage shield 20 when shield 20 isin the first position. A torsional spring 166 is mounted adjacent distalend 48 of hub 36 and between distal face 162 of dorsal fin 160 andshield 20. Torsional spring 166 is collapsed and in a stored energycondition when shield 20 is engaged by locking detent 164.

[0067] The assembly of FIGS. 21-23 can be used substantially in theconventional manner by holding dorsal fin 160 and guiding needle cannula34 into a targeted blood vessel. Upon completion of the medicalprocedure, the health care worker withdraws needle cannula 34 from theblood vessel and exerts a distal force on distal end 62 of shield 20.The force on shield 20 must be sufficient to overcome the holding forcesof locking detent 164. Torsional spring 166 then releases its storedenergy and propels shield 20 from the first position into the secondposition for safely surrounding needle cannula 34. Torsional spring 166will continue to exert forces on shield 20 for holding shield 20 in itssecond position. However, more positive locked retention of shield 20 inthe second position can be provided by a cannula finger lock as in thepreceding embodiments.

[0068] A twelfth embodiment of the subject invention is illustrated inFIGS. 24 and 25 and is similar to the eleventh embodiment. Moreparticularly, the twelfth embodiment includes a needle 34 and a needlehub 36. Needle hub 36 includes a distal end 48 and needle cannula 34extends therefrom. Wings 54 and 55 project transversely from hub 36. Aneedle shield 170 is hingedly connected to distal end 48 of needle hub36. Needle shield 170 is in the form of a dorsal fin, and hencefunctions in a manner similar to the dorsal fin 160 of the eleventhembodiment illustrated in FIGS. 19-21 and described above. Moreparticularly, shield 170 is a planar structure with a distal face 172having an elongate groove 174 formed therein. Groove 174 is dimensionedand configured to receive needle cannula 34. The interior portions ofgroove 174 may include structure for locking needle cannula 34. Forexample, one or more cannula finger locks may be provided. Needle shield170 further is provided with structure for releasable engagement ofproximal portions of shield 170 with needle hub 36. The releasableengagement may be a locking detent similar to the locking detent 164 ofthe eleventh embodiment, latches similar to the latches 114 of the sixthembodiment illustrated in FIG. 10, an over center hinge constructionsimilar to the seventh embodiment illustrated in FIGS. 11 and 12 or afrangible connection. With each of these optional constructions, needlecannula 34 can be used by manipulating shield 170 substantially in thesame way as the manipulation of dorsal fin 160 of the eleventhembodiment. After use, needle cannula 34 is withdrawn from the patient.The health care worker then exerts a distal force on the proximal sideof shield 170. As a result, the connection between shield 170 and needlehub 36 is separated, and shield 170 is propelled about the hingedconnection to distal end 48 of needle hub 36 and into shieldingengagement around needle cannula 34.

[0069] A thirteenth embodiment of the subject invention is illustratedin FIGS. 26-28 and includes a needle cannula 34 projecting from theneedle hub 36. Wings 54 and 55 project transversely from needle hub 36.A shield 180 is hingedly connected to needle hub 36 and can be rotatedfrom a first position where needle cannula 34 is exposed for use to asecond position where shield 180 surrounds needle cannula 34. Shield 180may be provided with structure for locked engagement with needle cannula34, such as resiliently deflectable cannula locking fingers. Unlike theabove-described embodiments, shield 180 is formed with a narrowlongitudinal slot 182 on the side thereof opposite the elongate openinginto which needle cannula 34 is received. Slot 182 may be substantiallynarrower than the needle-receiving opening of shield 180.

[0070] The assembly of FIGS. 26-28 further includes a hinged actuator184. Actuator 184 has a proximal end 186 hingedly attached to hub 36 ata location proximally of the hinged connection of shield 36 to hub 34.Actuator 184 further includes a distal end 188. Portions of actuator 184between proximal and distal ends 186 and 188 are slidably received inslot 182 of shield 180. Additionally, actuator 184 includes proximal anddistal detents 190 and 192 that are spaced from one another by adistance slightly greater than the thickness of the plastic materialfrom which shield 180 is formed. Distal detent 192 is snapped into slot182 of shield 180 such that portions of actuator 184 between proximaland distal detents 190 and 192 are slidable in slot 182. With thisconstruction, shield 180 can be rotated into a first position whereneedle cannula 34 is exposed for use. After use, distally directedforces can be exerted on actuator 184 by a thumb of the user of thedevice. These distally directed forces will cause actuator 184 to pivotaround its proximal end 186. Simultaneously, proximal detents 190 willexert forces on the top wall of shield 180 adjacent slot 182 therein.Hence, shield 180 will pivot about needle hub 36 and into the secondposition surrounding needle cannula 34. Locking structures in shield 180then will lockingly engage needle cannula 34.

[0071] The fourteenth embodiment of the subject invention is illustratedin FIGS. 29 and 30. The fourteenth embodiment includes a needle cannula34 and a needle hub 36 substantially similar to a needle cannula and hubdescribed with respect to the preceding embodiments. The fourteenthembodiment further includes wings 200 and 202 projecting transverselyfrom opposite sides of hub 36. However, unlike the precedingembodiments, at least one wing 200 is substantially hollow and includestop and bottom walls 204 and 206 with a planar slot 208 extendingdistally between walls 204 and 206. Top wall 204 is formed with anarcuate slot 210 formed therethrough and extending through an arcgenerated about a location at or near the distal end of needle hub 36. Ashield 212 is hingedly connected to hub 36 substantially at the centerof rotation of arcuate slot 210 in top wall 204 of wing 200. Shield 212includes an actuating projection 214 that extends through slot 210. Theassembly shown in FIGS. 29 and 30 can be used substantially in aconventional manner by gripping wings 200 and 202 and inserting needlecannula 34 into the targeted blood vessel or other such source of bodilyfluid. Upon completion of collection of fluid specimens, needle cannula34 is withdrawn from the patient. The health care worker then movesactuating 214 of shield 212 through slot 210 in wing 200. As a result,shield 212 pivots about needle hub 36 sufficiently for shield 212 tosubstantially envelope and engage needle cannula 34.

What is claimed is:
 1. A safety needle assembly comprising a needle hubhaving opposite proximal and distal ends, a needle cannula having aproximal end connected to said distal end of said needle hub and adistal end projecting distally from said needle hub, wings projectingtransversely from said hub, a needle shield hingedly connected to saidneedle hub and movable from a first position where said needle cannulais exposed to a second position where said needle cannula is shielded bysaid shield, locking means provided on said safety needle assembly at atleast one location proximally of said needle cannula for lockedengagement with said shield when said shield is in said second position.2. The safety needle assembly of claim 1, wherein the locking meanscomprises means for substantially permanently locking said shield insaid second position.
 3. The safety needle assembly of claim 2, wherein,said locking means comprises at least one finger projecting from saidshield and configured for locked engagement with at least one of saidwings.
 4. The safety needle assembly of claim 3, wherein at least one ofsaid wings includes a locking aperture formed therethrough, said shieldhaving at least one locking finger configured for projecting throughsaid locking aperture and lockingly engaging said wings when said shieldis in said second position.
 5. The safety needle assembly of claim 4,wherein the locking finger defines a ratchet having a plurality of pawlsformed thereon, said pawls being configured for engaging portions of atleast one said wing adjacent said locking aperture, said pawls beingconfigured for permitting movement of said shield from said firstposition toward said second position and being configured for preventingmovement of said shield toward said first position.
 6. The safety needleassembly of claim 3, wherein the locking means comprises proximal anddistal latches formed on said shield for locked engagement with proximaland distal edges of at least one said wing when said shield is in saidsecond position.
 7. The safety needle assembly of claim 1, furthercomprising a dorsal fin projecting rigidly from said needle hub, saidshield being formed with a slot therein, said dorsal fin projectingthrough said slot for permitting movement of said shield from said firstposition toward said second position, said dorsal fin being formed witha plurality of locking detents thereon for engaging portions of saidshield adjacent said slot, at least one said detent being configured forreleasably engaging said shield in said first position, and at least asecond of said detents being configured for permanently engaging saidshield in said second position.
 8. The safety needle assembly of claim1, further comprising a shield mount securely mounted to said proximalend of said needle hub, said shield being unitarily joined to saidshield mount, said shield mount further including a plurality ofresiliently deflectable latches extending therefrom, said latches beingconfigured to lockingly engage said shield when said shield is rotatedinto said second position.
 9. The safety needle assembly of claim 1,wherein said locking means comprises an over center hinge for urgingsaid shield from a position intermediate said first and second positionsinto said second position and for resisting movement of said hinge awayfrom said second position.
 10. The safety needle assembly of claim 1,wherein said locking means comprises an over center spring for urgingsaid shield from a position intermediate said first and second positionsinto said second position and for resisting movement of said hinge awayfrom said second position.
 11. The safety needle assembly of claim 1,wherein said shield extends proximally beyond said proximal end of saidhinged connection of said shield to said needle hub, proximal portionsof said shield including locking structures for locked engagement withportions of said safety needle assembly proximally of said hingedconnection.
 12. The safety needle assembly of claim 11, furthercomprising flexible plastic tubing securely connected to said proximalend of said needle hub and extending proximally therefrom, proximalportions of said shield being configured for secure connection to saidplastic tubing.
 13. The safety needle assembly of claim 1, furthercomprising means for locked engagement of said safety shield with saidneedle cannula.
 14. A safety needle assembly comprising a needle hubhaving opposed proximal and distal ends, a needle cannula projectingdistally from said distal end of said needle hub, wings projecting fromsaid needle hub, a safety shield hingedly connected to said needle hubfor hinged movement from a first position where said needle cannula isexposed to a second position where said needle cannula is shielded,biasing means for biasing said safety shield to said second position.15. The safety needle assembly of claim 14, further comprising retainingmeans for releasably retaining said shield in said first position andagainst the force of said biasing means.
 16. The safety needle assemblyof claim 15, wherein said shield is hingedly connected to said distalend of said needle hub, and wherein said shield is aligned substantiallyparallel to and adjacent said needle hub when said shield is in saidfirst position, said retaining means comprising a shield latchprojecting from said proximal end of said hub for releasable engagementwith said shield and for releasably holding said shield in said firstposition.
 17. The safety needle assembly of claim 15, further comprisinga dorsal fin, the retaining means for releasably retaining said shieldin said first position being formed on said dorsal fin.
 18. The safetyneedle assembly of claim 17, wherein at least a portion of said dorsalfin is resiliently deflectable for selectively releasing said retainingmeans and permitting said biasing means to propel said shield to saidsecond position.
 19. The safety needle assembly of claim 15, whereinsaid biasing means comprises a living hinge extending unitarily betweensaid distal end of said needle hub and said shield, said living hingebeing biased for positioning said shield in said second position. 20.The safety needle assembly of claim 15, wherein said biasing means is atorsional spring disposed between said shield and a portion of said hub.